Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection

Phase 2TerminatedNCT00962936

CureTech Ltd13 enrolled

Overview

This study aims to evaluate whether an investigational monoclonal antibody, CT-011, is safe to give and if it helps patients with hepatitis C virus (HCV). Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Results of this trial will help doctors obtain additional information with regard to the safety and efficacy of CT-011 as a potential treatment for HCV.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

CT-011DRUG

CT-011

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient is between 18 and 60 years of age, both genders. 2. Biopsy proven infection with Hepatitis C genotype 1. 3. Positive for anti-HCV. 4. Chronically infected for at least 3 months from diagnosis. 5. ECOG performance status ≤ 1. 6. Previous therapy with interferon +/- Ribavirin or Peginterferon +/- Ribavirin or ineligibility for this type of therapy or for liver transplantation. Exclusion Criteria: 1. Patients who received any type of anti viral treatment during the 3 months prior to enrollment. 2. Any history or active malignancy. 3. History of major organ transplantation with an existing functional graft. 4. Patients who received any systemic concurrent therapy within the last 4 weeks. 5. Patients progressing to acute liver failure (ALF).

Locations (1)

Hadassah Medical Center

Jerusalem, Israel

Outcomes

Primary Outcomes

To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection

Time frame: 12 months

Data from ClinicalTrials.gov

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